An expert panel under the health ministry has endorsed a nasal influenza vaccine for children between the ages of 2 to 18, paving the way for the first-ever approval of a nasal spray vaccine in Japan.
Based on the results of a clinical trial involving children in Japan, the panel agreed on Monday that the vaccine FluMist Quadrivalent is safe and effective in preventing the flu. The ministry is expected to approve the vaccine by around late March.
FluMist is a live attenuated vaccine that contains four flu strains, according to AstraZeneca, which developed the vaccine. In 2015, the British-Swedish pharmaceutical giant entered a licensing agreement with Daiichi Sankyo, through which the latter has the rights to develop and sell the product in Japan.
The nasal spray vaccine, administered in over 30 countries including the U.S., has been favored by some people who fear needles and the pain they can cause. While Daiichi Sankyo filed for approval for FluMist in 2016, it took years for the vaccine to get the panel¡¯s OK because some of the clinical trial data did not meet the criteria set out by the trial protocol, ministry officials said.
Some doctors in Japan have imported FluMist from abroad to administer to patients between the ages of 2 to 49 who prefer nasal vaccines over flu shots. But because the privately imported vaccines, which cost around ?9,000 ($66) to ?10,000, are not approved by the ministry, people receiving them are not eligible for compensation from the government if they experience serious damage to their health.
A runny nose, throat pain and coughs have been reported after taking the nasal vaccine.
Flu shots are voluntary in Japan, but people the age of 65 or older, and those over 60 who are immunocompromised or have certain diseases, can have part of the cost subsidized by the government. Other people who receive them, including children, pay the full cost, which is around ?3,000 to ?5,000 per shot.
Meanwhile on Tuesday, the health ministry approved Pfizer¡¯s bivalent COVID-19 booster shot for children between the ages of 5 to 11. Previously, children in this age group only had access to COVID-19 shots designed to protect against the original strain.
The bivalent booster is designed to protect against the original strain and the BA.4 and BA.5 sublineages of the omicron variant.
As of Tuesday, 23.2% of children between the ages of 5 to 11 had received two COVID-19 shots, while only 8.9% had received three shots of the vaccine.

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